A variety of conditions such as spondylolysis, disc herniation, compression of spinal cord nerve roots, degenerative disc disease, and trauma are known to cause severe discomfort, requiring medical attention. Among the procedures currently used to alleviate such conditions are spinal fusion, such as intervertebral and posterolateral fusion or arthrodesis. In these procedures, two adjacent vertebral bodies are fused together. The affected intervertebral disc is first excised, and an implant is inserted which accommodates bone growth between the two vertebral bodies to effectively bridge the gap left by the disc removal. A number of different implant materials and implant designs have been used for fusion with varying success. Although intervertebral and posterolateral fusion are widely used, drawbacks to their use include a reduced physiologic range of motion and other fusion related complications such as degeneration of adjacent discs and destabilization of the functional spinal unit. As a result, alternative treatments with fewer complications, but similar efficacy to fusion, are desirable. One such alternative to spinal fusion is arthroplasty and the use of a prosthetic or artificial disc.
In general, arthroplasty is used in the replacement of diseased joints. Arthroplasty involves a set of procedures directed to maintaining motion of the joint, thereby preserving its integrity and keeping the adjacent motion segments from deteriorating, as they tend to do after fusion. Depending on the location and the condition of the affected joint, specific arthroplasty procedures may be used. For example, interpositional reconstruction surgery, which reshapes the joint and adds a prosthetic disk between the two bones forming the joint is commonly used on elbow, shoulder, ankle, and finger joints. Total joint replacement, or total joint arthroplasty, replaces the entire diseased joint with an artificial prosthesis and, in recent years, has become the operation of choice for most knee and hip problems.
Hip and knee replacements are particularly widespread with nearly 300,000 hip replacements and about as many knee replacements performed in the United States in 2001. With respect to the knee and hip joint replacement surgeries, there are several implants or prosthetics available. For the hip prosthetic, in an exemplary design, there are two components, one is a metal ball attached to a metal stem which is fitted into the femur, and the second is a matching plastic socket which is implanted into the pelvis. The metal pieces are generally formed from stainless steel, alloys of cobalt and chrome, titanium, and alloys of titanium; the plastic pieces are generally formed from high-density polyethylene. For the knee prosthetics, in an exemplary embodiment, metal and plastic components are again used to replace the damaged bone ends and cartilage. The metal pieces are generally formed from stainless steel, alloys of cobalt and chrome, titanium, and alloys of titanium; the plastic pieces are generally formed from high-density polyethylene.
Although the evolution of spinal arthroplasty and the use of prosthetics in the spine has been similar to that of other joints in the body, evolving from fusing the joint to replacement the functional joint, the advent of spinal arthroplasty, however, has been slower than arthroplasty in other major joints in the body. A few of the possible reasons why spinal arthroplasty has been delayed are that spinal problems related to disc degeneration are difficult to diagnose, spinal procedures are typically crisis-driven and thus conservative solutions such as fusion are acceptable, and spinal anatomy is complex.
Over the past 40 years spinal arthroplasty technologies have been under development and in the last 10 years spinal arthroplasty has won the attention of leading surgeons and implant manufacturers. The evolution of spinal arthroplasty essentially began in the 1950's and one of several emerging concepts was the spherical concept of the disc prostheses. The spherical concept is simply the placement of a ball, essentially circumferential, the cavity of the nucleus pulposus after a discectomy procedure has been performed. The annulus is kept in place and the ball serves as a nucleus replacement device. Various materials have been experimented with for the spherical concept. For example, in the early 1960's, implants using silicone ball bearings were implanted into the cervical regions of the patents, but the outcomes were uncertain. In the mid 1960's, stainless-steel (ball bearing) prostheses were implanted into patients. The results of the procedure were initially promising but over time the disc spaces lost height due to subsidence of the steel balls into the vertebral bodies. Presently, the concept of a spherical prosthesis continues to be examined using different materials, the latest of which is a modified carbon fiber.
Another emerging concept is the mechanical concept design. The mechanical concept design is essentially a total disc replacement product which is intended to restore the range of motion of the vertebral motion segment unit. These devices are often comprised of metallic endplates fixed to the adjacent vertebral bodies via a stabilization mechanism and a core formed from polyethylene or other polymeric materials. Alternatively, instead of a core, bearing surfaces can be used, the bearing surface materials being ceramic-on-ceramic, metal-on metal, or metal-on-polyethylene. The mechanical design concept is based on the same principles as joint reconstruction products, such as knee and hip replacements, and a variety of mechanical design prostheses concepts have been proposed and continue to be proposed.
Another concept is the physiological concept. The physiological concept uses a hydrogel, elastomer, or polyurethane-based core which is intended to restore the disc function by absorbing and emitting fluid between the patient's vertebral endplates, while also maintaining the natural shock absorbing or cushioning function of the disc. The physiological concept devices are generally considered only a partial solution as they are designed to replace only the nucleus or a portion of the disc.
All of the approaches to disc replacement are aimed at some or all of the following: alleviating discogenic pain, restoring range of motion, maintaining the natural shock absorbing function of the disc, restoring normal form or disc height, and storing physiological kinematics. Generally, four exemplary types of artificial intervertebral discs have been developed for replacing a portion or all of an excised disc: elastomer/fluid filled discs, ball and socket type discs, mechanical spring discs and hybrid discs.
Elastomer/fluid filled discs typically include an elastomer cushion or a fluid filled chamber positioned between lower and upper rigid endplates. The cushions and chambers of these implants advantageously function, in mechanical behavior, similar to the removed intervertebral disc tissue.
Ball and socket type discs typically incorporate two plate members having cooperating inner ball and socket portions which permit articulating motion of the members during movement of the spine.
Mechanical spring discs typically incorporate one or more coiled springs disposed between metal endplates. The coiled springs define a cumulative spring constant that is designed to be sufficient to maintain the spaced arrangement of the adjacent vertebrae while allowing normal movement of the vertebrae during flexion and extension of the spine in any direction.
The fourth type of artificial intervertebral disc, the hybrid disc incorporates two or more of the aforementioned design principles. For example, one known hybrid disc arrangement includes a ball and socket joint surrounded by an elastomer ring.
While each of the foregoing prostheses addresses some of the problems relating to intervertebral disc replacement, each of the implants presents significant drawbacks. Thus, there is a need for an intervertebral implant that accommodates the anatomy and geometry of the intervertebral space sought to be filled as well as the anatomy and geometry of the ends of adjacent vertebral bodies, while providing reliability and simplicity in design. More particularly, there is a need for a spinal disc implant which provides stability for supporting the high loads applied to the vertebrae, permits sufficient mobility to allow the patient an approximate normal range of motion, provides for axial compression between adjacent vertebrae, and has shock absorption abilities.